MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number PL569T

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a ligating clips m/l 12/box (part # pl569t) was used during a procedure performed on (b)(6) 2022.According to the complainant, the first two (2) to three (3) clips worked fine, but then the magazine was pushed away from the clip bar (part # pl538r) at the next activation.This happened inside the patient's abdomen.The complaint device was returned to the manufacturer for evaluation.The patient was not injured.However, an additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: pl538r - shaft compl.D:10mm l:260mm - lot unknown.Pl510r - handle f/pl506r & pl508r - lot unknown.

Manufacturer Narrative

H6 codes - updated investigation: the investigation was carried out visually and microscopically.Here we found broken off noses, broken off latches and clip jams.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(2) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.If the cartridge is engaged not completely, has not been mounted correctly or was damaged during inserting, there is an impairment of product functionality.A too fast application, damaged cartridge during inserting or a cartridge which is engaged not completely could also lead to the described errors.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.According to the investigation results, a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13517269
• MDR Text Key: 287679562
• Report Number: 9610612-2022-00024
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04038653341375
• UDI-Public: 4038653341375
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52715594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL510R - LOT UNKNOWN; PL538R - LOT UNKNOWN
• Patient Outcome(s): Required Intervention